FDA Issues Warning About Alcoholism Drug Vivitrol's Side Effects

Alkermes Inc.’s signature drug, Vivitrol, used in treatment for alcohol addiction, has been linked to adverse reactions, including blood clots, swelling, abscesses and cell death, the U.S. Food and Drug Administration (FDA) warned today.

Vivitrol, approved by the FDA in 2006 to treat alcohol dependence in patients, alongside counseling and group therapy, is a once-a-month injection. The drug works by blocking neurotransmitters in the brain believed to be associated with alcohol dependence, thus diminishing the patients’ craving for alcohol.

However, since approval 200 cases of adverse reactions, including swelling, pain, bleeding and other complications have been reported; 16 patients required surgery, either to drain puss or for repair of damaged tissue, the U.S. health regulators said.

Not in consensus with the FDA warning, a spokeswoman for Cambridge, Massachusetts-based, Alkermes, and its U.S. marketing partner, Frazer, Pa.-based Cephalon Inc., Candace Steele, said, “The problems appeared to arise when doctors did not properly inject the drug into muscle tissue.”

To be injected into the patient’s buttock, health experts should ensure that the needle goes past the fat layer and reaches the gluteal muscles, she emphasized.

In the meantime, while FDA is working with company officials on a stronger, more prominent warning label, it urges doctors to make sure they are administering the injections correctly and with the proper needle.

Moreover, FDA officials advised patients to monitor the injection site and report for any worsening reactions, immediately.

Interestingly, unaffected by warnings issued in the US, the Russian Regulatory Authorities on August 4 approved Alkermes Inc. and its marketing partner, Cilag GmbH International, a subsidiary of Johnson & Johnson, to market Vivitrol for the treatment of alcohol dependence in Russia.